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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K121391
Device Name INCLUSIVE TITANIUM ABUTMENTS FOR CAMLOG SCREW-LINE IMPLANTS
Applicant
PRISMATIK DENTALCRAFT, INC.
2212 DUPONT DR., ST P
IRVINE,  CA  92612
Applicant Contact ARMIN ZEHTABCHI
Correspondent
PRISMATIK DENTALCRAFT, INC.
2212 DUPONT DR., ST P
IRVINE,  CA  92612
Correspondent Contact ARMIN ZEHTABCHI
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/09/2012
Decision Date 12/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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